Catheterization Tray With Bardex® All-Silicone Foley Catheter 791600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741029653), received between May 14, 2018 and Sep 13, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2020Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD TO REMOVE THE LAST FOLEY SURGICALLY AND THERE WERE NO SPECIFICS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Patient Problem/Medical Problem

  MAUDE report 10526245 ↗
• InjuryJun 17, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION AND HAD TO GO TO THE HOSPITAL. PATIENT ALSO STATED THAT THE INFECTION WAS IN BLOOD AND WAS TREATED WITH MEDICINE.

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 10165619 ↗
• InjuryMay 15, 2018Break

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BROKE OFF WHILE INSIDE THE PATIENT. THE PATIENT WENT TO THE HOSPITAL TO HAVE THE BALLOON REMOVED. THE PATIENT'S HUSBAND STATED THE PATIENT DID NOT REQUIRE SURGERY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7515557 ↗
• MalfunctionMay 14, 2018Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE WHEN THE PATIENT ATTEMPTED TO REMOVE THE FOLEY CATHETER. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7510231 ↗